Method: Healthy CMV-seronegative 18-40 year olds at 3 sites in Canada (Vancouver, Montreal, Halifax) were randomized to one of 4 dose formulations (0.5µg, 1µg, or 2µg gB content with Alum) or 1µg gB without Alum, or placebo given on days 0, 56 and 168. Outcome measures were solicited and unsolicited adverse events (AE), severe AE, gB binding antibody titers and avidity assessment, and nAb to CMV infection of fibroblast and epithelial cells. A Data Safety Monitoring Board was in place.
Result: Among 128 participants, the most common solicited local and general AEs were pain and headache, respectively. No SAEs or withdrawals occurred. A dose-dependent boosting of nAb titers was observed after doses 2 and 3, with the highest titers in the Alum-adjuvanted 2.0 µg dose recipients. Fibroblast cell nAb were seen in 100% of 2.0 µg dose recipients, and epithelial cell nAb in 31%. Epithelial cell nAb was correlated with higher geometric mean gB binding titers, and there was a correlation between fibroblast and epithelial cell nAb titers.
Conclusion: An eVLP CMV vaccine was immunogenic at very low doses in healthy seronegative adults and no safety signals were seen. Alum adjuvantation increased immunogenicity as did higher antigen content and multiple doses. This phase 1 trial supports further development of this eVLP CMV vaccine candidate.
No direct financial benefit-- company provided institutional support for clinical trial
D. E. Anderson, VBI Vaccines: Employee and Shareholder , Salary .
F. Diaz-Mitoma, VBI Vaccines: Consultant and Shareholder , Salary .
J. Langley, VBI Vaccines: Investigator , No direct financial benefit-- company provided institutional support for clinical trial .
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